Cefepime-Taniborbactam in Complicated Urinary Tract Infection

Area of Science:

• Infectious Diseases
• Pharmacology
• Clinical Medicine

Background:

• Carbapenem-resistant Enterobacterales and multidrug-resistant Pseudomonas aeruginosa pose significant global health threats.
• Cefepime-taniborbactam is an investigational antibiotic combination targeting these resistant pathogens.

Purpose of the Study:

• To evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in hospitalized adults with complicated urinary tract infections (cUTI).

Main Methods:

• Phase 3, double-blind, randomized trial comparing intravenous cefepime-taniborbactam to meropenem in patients with cUTI.
• Primary outcome: composite success (microbiologic and clinical) in the microbiologic intention-to-treat (microITT) population.
• Patients received study drug every 8 hours for 7 days, extendable to 14 days for bacteremia.

Main Results:

• Cefepime-taniborbactam achieved superior composite success (70.6%) versus meropenem (58.0%) in the microITT population (P=0.009).
• Treatment differences favoring cefepime-taniborbactam were sustained at late follow-up.
• Adverse event rates were similar between groups, with no significant difference in serious adverse events.

Conclusions:

• Cefepime-taniborbactam is superior to meropenem for treating complicated urinary tract infections, including acute pyelonephritis.
• The safety profile of cefepime-taniborbactam is comparable to meropenem.
• This study supports cefepime-taniborbactam as a potential new treatment option for resistant bacterial infections.